- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05229757
The Effect of Family Education on Functional Level, Activity Level and Families in Children With Cerebral Palsy
The activity status of children with cerebral palsy between the ages of 3 and 18 who participated in the physiotherapy program in special education institutions throughout the province of Gaziantep was evaluated. The effect of the family education to be given on the activity status of the children and the psychosocial status of the families was investigated.
The individuals included in the study were divided into two groups as patient and control. In the beginning, the scales used to determine the activity status and the scales to determine the depression status of their families were applied in order to determine the status of both groups. Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks. Individuals in the control group were followed up with a home program. After 8 weeks of treatment, the same tests were repeated and it was examined whether the family education provided made a difference in children with cerebral palsy and their parents.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Şahinbey
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Gaziantep, Şahinbey, Pavo, 27000
- Hasan Kalyoncu University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Be in the age range of 3-18 years.
- Getting a diagnosis of cerebral palsy.
- Agree to participate in the study.
Exclusion Criteria:
- If the child interrupts supportive education for any reason,
- Failure of the family to ensure continuity in participation
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Study Group
Children with cerebral palsy in the patient group received treatment in a special education and rehabilitation center two days a week for 8 weeks.
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Routine physiotherapy and rehabilitation practice was performed 2 days a week for 8 weeks in the special education and rehabilitation center.
|
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Comparador activo: Control Group
Individuals in the control group were followed with a home program for 8 weeks.
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Home exercise was applied by the families every day of the week for 8 weeks.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Abilhand Kids (For patients)
Periodo de tiempo: Change from Baseline Abilhand Kids at 8 weeks.
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It is a questionnaire consisting of 21 questions designed to test children's manual abilities.
The applicability of the items by the child is evaluated in 3 steps as impossible, easy and difficult.
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Change from Baseline Abilhand Kids at 8 weeks.
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GMFM 66 (For patients)
Periodo de tiempo: Change from Baseline GMFM 66 at 8 weeks.
|
Gross motor function assessment is a computerized test consisting of 66 questions.
Evaluates the sub-titles as Reaching-Rolling, Sitting, Standing and running-Jumping.
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Change from Baseline GMFM 66 at 8 weeks.
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PEDI (For patients)
Periodo de tiempo: Change from Baseline PEDI at 8 weeks.
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It is a scale that evaluates the functional skills of the child and the help and manner of the caregiver, in which each part is evaluated separately as self-care, mobility and social function items.
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Change from Baseline PEDI at 8 weeks.
|
|
Beck Depression Scale (For family)
Periodo de tiempo: Change from Baseline Beck Depression Scale at 8 weeks.
|
It is a survey aiming to reach the result by scoring between 0 and 3 with 21 questions.
According to the total score, it is divided into 4 groups as minimal, mild, moderate and severe depression.
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Change from Baseline Beck Depression Scale at 8 weeks.
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IPFAM (For family)
Periodo de tiempo: Change from Baseline IPFAM at 8 weeks.
|
The family impact scale asks for answers in 4 categories: I strongly disagree (4 points), disagree (3 points), agree (2 points), completely agree (1 point) in 27 questions.
Makes classification according to the total score.
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Change from Baseline IPFAM at 8 weeks.
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2021/048
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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